LEXETTE Topical foam (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Mayne Pharma

Λέξεις κλειδιά

51862-604

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1. Indications and Usage

LEXETTE is indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older.

2. Dosage and Administration

Shake can prior to use. Apply LEXETTE as a thin uniform film to the affected skin twice daily for up to two weeks. Rub in gently. Wash hands after applying the product. Discontinue therapy when control ...

3. Dosage Forms and Strengths

LEXETTE (halobetasol propionate) topical foam is a white to off-white topical foam. Each gram of LEXETTE, 0.05% contains 0.5 mg of halobetasol propionate.

4. Contraindications

None.

5. Warnings and Precautions

5.1 Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Adverse Endocrine Effects LEXETTE is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) ...

6. Adverse Reactions

The following adverse reactions are discussed in greater detail in other sections of the label: Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Adverse Endocrine Effects <em>[see Warnings ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

8.1. Pregnancy

Risk Summary There are no available data on LEXETTE use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Published data report ...

8.2. Lactation

Risk Summary There are no data on the presence of halobetasol propionate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production after topical application ...

8.4. Pediatric Use

Safety and effectiveness of LEXETTE in patients younger than 18 years of age have not been established. Because of higher skin surface area to body mass ratios, pediatric patients are at a greater risk ...

8.5. Geriatric Use

Clinical studies with LEXETTE included 131 subjects aged 65 years and over. No overall differences in safety or effectiveness were observed between these subjects and those younger than 65 years.

10. Overdosage

Topically applied LEXETTE can be absorbed in sufficient amounts to produce systemic effects <em>[see Warnings and Precautions (5.1)]</em>.

11. Description

LEXETTE is a hydroethanolic aerosol foam that contains a corticosteroid, halobetasol propionate intended for topical use. The chemical name of halobetasol propionate is 21-chloro-6α, 9-difluoro-11β, 17-dihydroxy-16β-methylpregna-1, ...

12.1. Mechanism of Action

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in plaque psoriasis is unknown.

12.2. Pharmacodynamics

Vasoconstrictor Assay A vasoconstrictor assay in healthy subjects with LEXETTE indicated that the formulation is in the super-high range of potency as compared to other topical corticosteroids; however, ...

12.3. Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of halobetasol propionate. In a 90-day repeat-dose toxicity study in rats, topical administration of LEXETTE at dose ...

14. Clinical Studies

LEXETTE was evaluated for the treatment of moderate to severe plaque psoriasis in two multicenter, randomized, double-blind, vehicle-controlled trials (Study 1 [NCT02368210] and Study 2 [NCT02742441]). ...

16.1. How Supplied

LEXETTE, 0.05% is a white to off-white foam. It is supplied in aluminum cans of: 50 grams (NDC 51862-604-50) 100 grams (2 cans of 50 grams) (NDC 51862-604-02)

16.2. Storage and Handling

Storage Store at 20°-25°C (68°-77°F); excursions permitted to 15ºC and 30ºC (59ºF to 86ºF). Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). This information is intended to aid in the safe and effective use of this medication. It is ...